Module 14 2022

24/03/2022

A SIMILAR TYPE OF ALGORITHM CAN BE APPLIED TO MEDICAL DEVICE PACKAGING

.. AS PART OF YOUR RISK ASSESSMENT

Masterclass: Lecture 8

The Organisation for Professionals in Regulatory Affairs

23

Suitability For Intended Use…

PROTECTION ● Multiplicity of factors that can cause damage to devices, including:

– Heat – Light – Microbial contamination – Water vapour ingress / egress – Reactive gases

– Mechanism damage – Radiation exposure – Chemical damage

Interactive Session

The Organisation for Professionals in Regulatory Affairs

24

12